How to Request Access

Instructions for Access to Repository Data

Regardless of funding, all requests for access to data and/or biospecimens from the NIMH RGR should be made
through the Request Access Form.

Access requests must be submitted under the nimhgenetics.org account of the Principal Investigator (PI)
who is requesting access to the distribution (the PI signing the Distribution Agreement).
*Please note that the Principal Investigator status applies only to those conducting
independent research and does not apply to students, post-docs, or research associates/lab
managers. Members of a PI(s) group may access the data, however, such requests must be submitted
through their PI(s).*

If the PI does not have an nimhgenetics.org account, they should create one from the Create an Account page. Accounts must be created using an
email account provided by the requesting PIs institution. *Open accounts, such as Yahoo or
Gmail, cannot be used. If you have previously registered with such an account, we ask you to either
re-register with your institutional email address or request the email for your account be changed
by contacting us at NIMH.genomics.resources@mail.nih.gov
prior to submitting your request.*

Co-investigators named in a request should be affiliated with the requesting PI's institution. *If
a co-investigator is not affiliated with the requesting PI's institution, an additional
Distribution Agreement executed by the co-investigator and his/her institution must be
provided and a separate request may need to be executed.*

All data and/or biospecimen access requests should consist of the following documents compressed in a zip file
for upload into the online portal. *Please verify that your zip file opens correctly on both Windows
and Mac platforms and contains all documents prior to upload.*

*If you are requesting sample access for a research project not supported through NIMH,
please indicate your intention to pay all access fees.*

Explain the role of any persons for whom additional biosketches are uploaded.

BIOSKETCH(ES): The biographical sketches of the applicant PI and all co-investigators
must be uploaded. Please follow the format described in section 4.6 of the PHS 398 instructions.
*Note: All co-investigators should be affiliated with the requesting PI's institution. If a
co-investigator is not affiliated with the requesting PI's institution, an additional Distribution
Agreement must be executed by the co-investigator and his/her institution and they may
need to execute a separate access request.*

RESOURCES AND ENVIRONMENT: A paragraph or two (no more than a page) describing the
applicable information requested in section 4.7 of the PHS 398 instructions.

FUNDING INFORMATION: Indicate if the proposed analysis is funded and list the funding
organization and grant number, or indicate whether the project is not funded (e.g., institutionally
supported), but will form the basis for a new grant application. If it is the latter, please indicate
to which NIH institute the application may be submitted. This section should include all sources of
funding for the request, with period of support and active/pending status.

STUDY DESCRIPTION: An approximately one page description of the study design that
includes an abstract, background, and significance.

DISTRIBUTION AGREEMENT: A Distribution Agreement signed by PI and
Institutional Signing Official. After the Data Access Committee approves the request, the
remaining signatures will be obtained by NIMH and a fully executed copy will be returned to signing
institution upon request. An agreement must be provided for each separate institution included
in the request. *Note that iPSCs or similar reprogrammed biomaterials may be the subject of a
patent application or covered by patent rights in one or more countries.* Except as
provided in this Agreement, no express or implied licenses to such patent rights are provided. For-profit
entities, in particular, should ensure that they obtain
appropriate licenses
for use of such biomaterials prior to signing the Distribution Agreement.

DATA/RESOURCE SHARING PLAN: This is required ONLY for biosample requests. A sharing
plan may be requested for data access depending on the proposed analysis. Please see the sharing
plan example provided. The plan must
include:

What data/analyses you will deposit in an NIMH/NIH designated database such as (e.g., dbGaP, NDA,
etc.)

On what timeline will data/analysis deposition occur (e.g., data deposited at 9 month intervals
after data validation). If you will be submitting data to dbGaP, please also complete and
include the dbGaP study registration documents (Instruction
Guide , Submission
Certificate Template ).

If generating renewable derivatives of NIMH RGR biospecimens (e.g., iPSCs from banked
fibroblasts, genetically modified versions of iPSCs), provide a timeline
for submission of these
derived biomaterials back to the NIMH RGR. All submissions should be complete by the project
end date, to be released to the research community under the governance of NIH after the
project end date.

SYNAPSE Data Access Token: *Please note that a Synapse token must be obtained
and submitted in your request for all investigators who plan to analyze the data. This is
required ONLY for data requests utilizing data from the following consortia:*

Please be thorough when compiling your request packet. Much of this information will be necessary for you to
properly complete the online access request form for our database. Your packet must match what you indicate in the
access request form. For questions regarding the application process, please contact the NIMH Genomics Resources
Support Team at NIMH.genomics.resources@mail.nih.gov.

*YOU WILL BE CONTACTED BY THIS TEAM IF ANY REQUIRED INFORMATION IS MISSING FROM YOUR APPLICATION. FAILURE TO
RESPOND TO REQUESTS FOR MORE COMPLETE INFORMATION WILL RESULT IN A DENIAL OF YOUR APPLICATION.*

Review Process for Access Requests

All requests for access to data and biospecimens from the NIMH RGR will be reviewed by a trans-NIH Data Access
Committee consisting of NIH Program Staff from NIDA, NIAAA, and NIMH. Each access request will be considered based
on the following by the Data Access Committee:

The experience and qualifications of the applicant PI and co-investigators;

Ethical considerations;

The applicant PI’s familiarity with the characteristics, limitations, and strengths of the
dataset/biospecimens;

The adequacy of the proposed research design;

The adequacy of the research environment;

The adequacy of the applicant PI’s funding resources to support the proposed study and;

The adequacy of the applicant PI’s agreement on data sharing as stipulated in the data/resource sharing plan.

Requesters will be informed of the Data Access Committee decision by email. Approved requests will include further
instructions to access the authorized data and biospecimens.

Related Information

To gain access to an updated version of a data distribution, the Principal Investigator (PI) must have an approved
and active data access approval at the time they submit the amendment through the online portal. If they submit the
amendment and the access approval has expired, the submission is denied, and the PI must submit a new request to
regain access to the distribution. When an amendment is approved, the original expiration date of the access
approval remains in effect.

Upload the form into approved access request packet via the online submission portal

Once the form has been completed, the user uploads the amendment into their previously approved access
request from their account on the online submission portal. The user will see the "Update Access to Newer
Distributions" page that provides a link to upload the form. After the form is uploaded, click the “Update
Access” button. This will create a new request that is linked to the original or “parent” request.

Amendment is reviewed by the NIMH Access Approval Administrator

Amendments to gain access to updated versions of distributions do not undergo review and approval by the
NIMH Repository Data Access Committee (DAC). Amendments are reviewed by the NIMH Access Approval
Administrator. The NIMH Access Approval Administrator will review the amendment to ensure it corresponds
with the correct distribution the PI was granted access to in their original request and check to make sure
it has been signed. The document must be signed by the PI and their institution’s Authorized
Representative.

Approval and notification

The amendment is approved by the NIMH Access Approval Administrator if it meets the above requirements via
the online portal. The PI will receive an e-mail notification upon its approval.